A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Public ClinicalTrials.gov record NCT07652723. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-label Randomized, Three-fold Cross-over, Single-center Interaction Study to Investigate the Influence of Multiple Doses of Acetylsalicylic Acid (ASA) (Aspirin) on the Pharmacodynamics of BAY 3389934 in Healthy Participants.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study treatment BAY3389934 is under development for people with blood clotting problems that occur due to sepsis. Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. It can eventually lead to tiny blood clots formation throughout the body. BAY3389934 aims to work by blocking two important blood clotting proteins, called Factor IIa (thrombin) and Factor Xa, both of which help in blood clotting. By blocking them, BAY3389934 may slow down or stop excessive clotting. Aspirin is a drug that prevents platelets from clumping together. People with sepsis are often given aspirin for underlying heart-related problems. Since aspirin and BAY3389934 both affect how the blood clots, each in a different way, it is important to check whether using them together is safe and whether they change each other's effects on blood clotting. The main purpose of this study is to find out how safe BAY3389934 is when given together with aspirin and to see how the two affect blood clotting in healthy participants. To do this, the researchers will assess the number and severity of medical problems in healthy adult participants after receiving BAY3389934 alone and in combination with aspirin and compare them with the medical problems when participants received either drug alone. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they are related to study treatments. All participants will receive a single dose of aspirin tablet prior to the study. Researchers will check their response to decide whether they can participate in the study. Eligible participants will then receive the following three treatments, each at different time and in a different order assigned randomly. Treatment A: • no treatment the day prior to receiving study treatment. • BAY3389934 as an infusion into a vein on Day 1. Treatment B: • a single high-dose aspirin tablet on the day prior to receiving study treatment. • a single-low dose aspirin tablet on Day 1. Treatment C: • a single high-dose aspirin tablet on the day prior to receiving study treatment. • a single low-dose aspirin tablet followed by BAY3389934 4 hours continuous infusion into a vein on Day 1. There will be a gap of 3 days after Treatment A, and 14 days after Treatments B and C, when participants will not be given any treatment. Each participant will be in the study for around 2 months with up to 6 visits to the study clinic. They will visit the study clinic: • twice, before the treatment starts •once, during each of the three treatment periods •once, at the end of the treatment During the study, the doctors and their study team will •check participants' health by performing tests such as blood and urine tests, measuring blood pressure, heart rate and checking heart health using an electrocardiogram (ECG). •ask the participants questions about how they are feeling and any adverse events they are having. In this study, the participants will not benefit from taking of BAY3389934. However, the study will provide information on how BAY3389934 may be helpful in people with blood clotting problems caused due to sepsis.
Study identification
- NCT ID
- NCT07652723
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2026
- Primary completion
- Nov 10, 2026
- Completion
- Nov 10, 2026
- Last update posted
- Aug 25, 2026
2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC - Cardiology Department | Miami | Florida | 33014 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07652723, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07652723 live on ClinicalTrials.gov.